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23andMe Suspends Health-Related Data Interpretation for New Customers

NEW YORK (GenomeWeb News) – Direct-to-consumer testing firm 23andMe has decided to comply with the US Food and Drug Administration's wishes and discontinue providing health-related genetic data interpretation services to new customers.

In a Nov. 22 warning letter, signed by Alberto Gutierrez, director of FDA's Office of In Vitro Diagnostics and Radiological Health, the agency asked 23andMe to "immediately discontinue marketing" its Personal Genome Service "until such time as it receives FDA marketing authorization for the device." The agency gave 23andMe 15 days to respond to its letter and explain why the company had failed to garner FDA's okay for its Personal Genome Service.

23andMe has decided to maintain access to health-related reports for customers who received such data from the company before the FDA warning letter dated Nov. 22. Those who purchased kits before that date will also continue to receive health-related results. Customers who purchased kits from the firm on or after Nov. 22 will only receive ancestry-related information and their raw genetic data.

A more in-depth article published earlier this week in PGx Reporter discussed such a possibility. The FDA hasn't taken issue with companies like National Geographic and Gene by Gene, which provide DTC genetic testing for ancestry tracking. The agency also hasn't objected to companies providing people direct access to their raw genomic data, without interpreting what that information means for their health.

23andMe noted that its "new customers may receive additional health-related results in the future, dependent upon FDA marketing authorization," but for the time being, they will receive a refund.

In addition to providing ancestry-related information and raw genetic data without interpretation, the Mountain View, Calif.-based firm will continue its research and educational efforts.

"We remain firmly committed to fulfilling our long-term mission to help people everywhere have access to their own genetic data and have the ability to use that information to improve their lives," Anne Wojcicki, co-founder and CEO of 23andMe, said in a statement. "Our goal is to work cooperatively with the FDA to provide that opportunity in a way that clearly demonstrates the benefit to people and the validity of the science that underlies the test."